Events

Safety Alert for RESOLUTION CLIP DEVICE - Registered in Anvisa under the number 10341350360 - M00522610 - Lot: 0ML9042702 - Boston Scientific do Brasil.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Boston Scientific do Brasil Ltda..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    973
  • Date
    2009-07-30
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Extra notes in the data
    We are aware that hospitals often remove the products from their outer packaging and store them on hospital shelves, only in their internal pouches. If this is a practice in your unit, it is very important that you carefully use the table below and consider both the internal code and the external code of the product packaging when searching for affected products of this voluntary recall, since UPN Codes on the labels of the inner packagings of the product are different from those on the outer packagings. The product information listed on your specific Verification and Traceability Response Form (which is attached to this alert). Source: Boston Scientific. ### Update on 11/09/2009 - The company informed Anvisa of the closure of the action for the collection of the affected products through file 749932 / 09-9 dated 10/01/2009.
  • Reason
    It was identified during a manufacturer's inspection and testing process that the torque conductor used to insert the set of screws that connect the control wire to a cross pin of the resolution® clips device was out of calibration. this may result in an inability to position or release catheter.
  • Action
    The actions recommended to product users are as follows: (1) Immediate discontinuation of use and segregation of the affected product in this alert. (2) Complete and return the verification and traceability response form to: Boston Scientific of Brazil - A / C: Carolina Yin - Fax: (11) 5502-8510 or e-mail: yinc@bsci.com.

Device

RESOLUTION CLIP DEVICE - Registered in Anvisa under the number 10341350360 - M00522610 - Lot: 0ML...

Manufacturer

Boston Scientific do Brasil Ltda.
  • Source
    ANVSANVISA